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    Latin America ? Understanding Regulatory Compliance Requirements Across the Life Science Industry

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    Website | Edit Freely

    Category Medical Device

    Deadline: January 15, 2027 | Date: January 15, 2027

    Venue/Country: Houston, U.S.A

    Updated: 2014-12-09 19:14:08 (GMT+9)

    Call For Papers - CFP


    Why Should You Attend:

    This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. Other countries such asChile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will be discussed. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.

    The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution.

    Webinar Includes:

    Online course manual available for free with your purchase!

    And remember, you’ll get a chance to ask your toughest questions during the Q&A session

    Location: Your office or conference room (no need to travel!)

    Certificate of Attendance

    Areas Covered in the Seminar:

    Glossary of Terms.

    Defining the Opportunity.

    Country Facts: Argentina, Brazil, Mexico.

    Latin America's Regulatory Structure for the Life Science Product Industries

    Mercosur - Southern Common Market.

    Beginning Your Company Involvement in Latin America: Examples of Country Requirements.

    Registration / Required Country Licenses.

    Common Fees

    Overview of the Rules Governing Medicinal Products & Medical Devices

    Select Examples of:Clinical Trials, GCP, GMP, Specials, Marketing Authorizations, Product Classifications, Scientific Advice, Generics Pricing, Patents, Labeling, SPC, Variations, Manufacturing Licenses, Renewals, Pharmacovigilance, Orphan Drugs.

    Marketing Authorization Processes - Filings & Registrations

    Drug vs. Medical Device vs. Biologic vs. Combination Product

    Drug Master File (DMF) Use in Latin America Registration

    Use of Expert Reports.

    Processing Variations on Licensed Products

    Variations: Changes to Marketed Products.

    Types of Variations.

    Dossier Maintenance Expectations.

    Changes Concerning Manufacturing Aspects (Product & Process).

    Labeling & Packaging Leaflet Requirements

    Orphan Drugs / Rare Diseases

    Comparing and Contrasting Latin American Procedures vs. the U.S. FDA

    Comparison of Processes.

    Agency Interactions.

    Accepted Practices.

    How and When to Influence the Regulatory Process

    Accepted Country Practices.

    Effective Monitoring Activity.

    Association vs. Individual Company Involvement & Intervention.

    The Regulatory Negotiation Process

    Effective Approaches.

    The Do's and Don'ts of Regulatory Involvement.

    How to Use Regulations / Regulatory Contacts to Your Advantage

    Check-in Procedure.

    Agency Interactions.

    Business Impact Within and Outside Latin America.

    Professionalism in Regulatory Lobbying.

    Resources / Helpful Websites

    Who Will Benefit:

    This course will be beneficial to:

    Regulatory personnel whose responsibilities require knowledge of the Latin American regulatory environment

    Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements

    QA / QC Personnel

    Global Supply Chain personnel

    Clinical / Pharma & Device personnel

    Manufacturing personnel

    Global Business Development personnel

    Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization

    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.